Congenital Hyperinsulinism Clinical Trial
Official title:
Role of GLP-1 in Congenital Hyperinsulinism:Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
Verified date | March 2020 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).
Status | Completed |
Enrollment | 17 |
Est. completion date | January 2017 |
Est. primary completion date | August 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: - Confirmed diagnosis of hyperinsulinism - Mutation analysis results demonstrating KATP channel defect - Age 6 months to 18 years with - Persistent hypoglycemia Exclusion Criteria: - Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1 - Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure - Pregnancy - Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Diva De Leon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve (AUC) Plasma Glucose | Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion | Time 0 min - time 360 min | |
Secondary | Area Under the Curve (AUC) Plasma Insulin | Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion | time 0 min to time 360 min | |
Secondary | Area Under the Curve (AUC) Plasma C-peptide | Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion | time 0 min to time 360 min | |
Secondary | Area Under the Curve (AUC) Plasma Glucagon | Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion | time 0 min to time 360 min | |
Secondary | Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) | Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion | time 0 to time 360 min | |
Secondary | Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1) | Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion | time 0 min to time 360 min |
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